Gefitinib along with methotrexate as palliative therapy in PS 3 and above in metastatic squamous cell carcinoma head and neck cancer patients

Abstract

Abstract Background Metronomic chemotherapy is one of the proven methods for treatment of terminally ill patients with malignancy, who are otherwise not fit for chemotherapy. The literature (IJMPO 2013:34 11-15) suggested that it has been used in patients with PS1/2. However, it was never used in PS 3 and above and it is worth exploring the same as the adverse event profile was very limited with the treatment. With encouraging results of above publications, we explored the possibility of using Gefitinib methotrexate 15\xa0mg either alone or in combination in patients with advanced head and neck cancers in view of the limited options and literature availability for subjects with PS 3 and more. Methods Aim- Analysis of Gefitinib 250\xa0mg once a day vs methotrexate 15\xa0mg once a week vs combination in patients with advanced head and neck cancers safety and efficacy. We collected the details of the 78 subjects with pre-treated advanced refractory or progressive solid tumors having PS of more than 2. Case records between 2017 September and 2018 September were analyzed, 78 patients were found suitable for analysis. Patients received gefitinib (250\xa0mg/day), methotrexate as 15\xa0mg intramuscular weekly or a combination. Patients were stratified into those with improved PS and those without. The subjects without PS improvement were continued on the single agent and those with improvement were offered additional chemotherapy based on the primary site. Results Out of 78 subjects, 49 had improvement in the PS and were continued later. 19 subjects had stable PS and disease. 10 subjects had worsening of PS. Fifty-two subjects have clinically meaningful response (stable disease + complete + partial responses) and had symptomatic improvement. The median PFS was 248 days (95% CI, 104 to 282), and the median improvement in QOL was 9 points on a scale of 30. Conclusions Gefitinib 250\xa0mg once a day, methotrexate 15\xa0mg once a week, or combination is well tolerated and may have a role in the treatment of advanced cancers with poor performance status. Majority of the patients who are otherwise not eligible beyond palliative care now had better QOL and longer PFS, which re-emphasizes role of metronomic therapy in advanced squamous cell carcinoma of head and neck regions. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.